The purpose of this study is to determine the effect of ABT-869 plus paclitaxel compared to paclitaxel alone on disease progression in metastatic breast cancer.

Detailed Description

Only the open-label lead-in portion of the study was enrolled (n=10). The randomized portion was not initiated. N = approximately 102 (90 randomized in a 1:1 ratio in Phase 2, approximately 6-12 enrolled in open-label lead-in to assess the tolerability of the combination) Phase 2, randomized, placebo-controlled, double-blind, multi-center study of the efficacy and tolerability of the ABT-869 + paclitaxel versus placebo for ABT-869 + paclitaxel in subjects with documented metastatic breast cancer in the first line metastatic therapy setting. An initial open-label, lead-in cohort of six subjects will be monitored for 2 cycles (8 weeks) to assess the PK interactions and the safety of the combination of 0.20 mg/kg QD ABT-869 and paclitaxel (90 mg/m2). Enrollment into the randomized portion will begin after a cohort has completed two cycles (8 weeks) of therapy and no toxicities prohibit the cohort from continuing on to Cycle 3. Alternative doses may be explored based on the tolerability of the combination.

0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle

Drug: paclitaxel

90 mg/m2 IV infusion over 1 hour, weekly every 3 out of 4 weeks

Drug: Placebo for ABT-869

0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle

Study Arm (s)

Active Comparator: A

In study, this arm is a randomized (blinded) to ABT-869 arm plus paclitaxel.

Note: Prior to randomization, approximately 6-12 subjects will be enrolled in open-label lead-in to assess the tolerability of the combination. The initial open-label, lead-in cohort of six subjects will be monitored for 2 cycles (8 weeks) to assess the PK interactions and the safety of the combination of 0.20 mg/kg QD ABT-869 and paclitaxel (90 mg/m2). Enrollment into the randomized portion will begin after a cohort has completed two cycles (8 weeks) of therapy and no toxicities prohibit the cohort from continuing on to Cycle 3.

Alternative doses may be explored based on the tolerability of the combination

Interventions:

Drug: ABT-869

Drug: paclitaxel

Placebo Comparator: B

In study, this arm is a randomized (blinded) to placebo for ABT-869 plus paclitaxel arm.

Note: Prior to randomization, approximately 6-12 subjects will be enrolled in open-label lead-in to assess the tolerability of the combination. The initial open-label, lead-in cohort of six subjects will be monitored for 2 cycles (8 weeks) to assess the PK interactions and the safety of the combination of 0.20 mg/kg QD ABT-869 and paclitaxel (90 mg/m2). Enrollment into the randomized portion will begin after a cohort has completed two cycles (8 weeks) of therapy and no toxicities prohibit the cohort from continuing on to Cycle 3.

Alternative doses may be explored based on the tolerability of the combination

Interventions:

Drug: paclitaxel

Drug: Placebo for ABT-869

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Subject has received anti-cancer therapy (other than chemotherapy) including investigational agents, or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to Study Day 1.

Subject has not recovered to less than or equal to grade 1 clinically significant adverse effects/toxicities of the previous therapy.

Subject has received radiation therapy within 14 days of Study Day 1.

Subject has received anti-cancer hormonal therapy within 14 days of Study Day 1.

Subject has undergone major surgery within 21 days of Study Day 1.

The subject has untreated brain or meningeal metastases.

Subject is receiving therapeutic anticoagulation therapy.

Subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis).